Lutathera ® receives NICE approval for GEP-NETs

Advanced Accelerator Applications, a Novartis company, welcomes the publication of the National Institute for Health and Care Excellence (NICE) Final Appraisal Document (FAD) for Lutathera ® (lutetium oxodotreotide), for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.

NICE has announced that it has recommended lutetium (177Lu) oxodotreotide as a treatment option in adults within its marketing authorisation and for all approved indications of progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs). This means that the treatment will now be available to patients via the NHS in England.

GEP-NETs, are a group of tumours originating in the neuroendocrine cells of numerous organs. The estimated incidence of gastrointestinal NETs in the UK is approximately 2.65 per 100,000 per year, while the estimated incidence of pancreatic NETs in the UK is less than 0.2 per 100,000 per year.

Lutetium (177Lu) oxodotreotide is a 177Lu-labeled somatostatin analog peptide. It belongs to an innovative form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting tumours with radiolabeled molecules that bind to specific receptors expressed by the tumour.

This positive recommendation is based on key evidence, including the results of a randomised, open label, phase 3 study, NETTER-1, in 229 patients with inoperable, metastatic or locally advanced, progressive midgut NET, which included head to head data comparing lutetium (177Lu) oxodotreotide with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under standard Octreotide LAR treatment and overexpressing somatostatin receptors.

Additionally, data to inform efficacy was used from the Erasmus phase 1/2 trial. This was conducted in more than 1,200 patients with a wide range of NET indications including foregut (pancreatic), midgut and hindgut.

Germo Gericke, M.D., Head of Research and Development at Advanced Accelerator Applications commented “Lutetium (177Lu) oxodotreotide is the first treatment of its kind to receive regulatory approval and it is our hope that being recognised by NICE as a cost-effective treatment for all approved indications will facilitate broad availability of this therapy for GEP-NET patients in England.”

Professor Martyn Caplin, Professor of Gastroenterology and Tumour Neuroendocrinology at the Royal Free London Hospital and University College London said, “The clinical trial data and real-life experience of lutetium (177Lu) oxodotreotide indicate that this is a clinically beneficial treatment for GEP-NET patients with advanced disease.”

Previously Lutathera® was recommended by The Scottish Medicines Consortium: